批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2025/04/15 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 无 |
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
>>>活性成分:ESOMEPRAZOLE MAGNESIUM; 剂型/给药途径:FOR SUSPENSION, DELAYED RELEASE;ORAL; 规格:EQ 5MG BASE/PACKET; 治疗等效代码:AB<<<
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021957 |
004 |
NDA |
NEXIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 5MG BASE/PACKET |
Prescription |
Yes |
No |
AB |
2011/12/15
|
ASTRAZENECA |
| 217714 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 5MG BASE/PACKET |
Prescription |
No |
No |
AB |
2025/01/07
|
CIPLA |
| 212651 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 5MG BASE/PACKET |
Prescription |
No |
No |
AB |
2025/03/05
|
TORRENT |
| 218948 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 5MG BASE/PACKET |
Prescription |
No |
No |
AB |
2025/04/15
|
AUROBINDO PHARMA LTD |
>>>活性成分:ESOMEPRAZOLE MAGNESIUM; 剂型/给药途径:FOR SUSPENSION, DELAYED RELEASE;ORAL; 规格:EQ 20MG BASE/PACKET; 治疗等效代码:AB<<<
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021957 |
001 |
NDA |
NEXIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 20MG BASE/PACKET |
Prescription |
Yes |
No |
AB |
2006/10/20
|
ASTRAZENECA |
| 211751 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 20MG BASE/PACKET |
Prescription |
No |
No |
AB |
2020/03/23
|
CIPLA |
| 206055 |
001 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 20MG BASE/PACKET |
Prescription |
No |
No |
AB |
2023/06/07
|
ZYDUS PHARMS |
| 212651 |
003 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 20MG BASE/PACKET |
Prescription |
No |
No |
AB |
2025/03/05
|
TORRENT |
| 218948 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 20MG BASE/PACKET |
Prescription |
No |
No |
AB |
2025/04/15
|
AUROBINDO PHARMA LTD |
>>>活性成分:ESOMEPRAZOLE MAGNESIUM; 剂型/给药途径:FOR SUSPENSION, DELAYED RELEASE;ORAL; 规格:EQ 40MG BASE/PACKET; 治疗等效代码:AB<<<
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021957 |
002 |
NDA |
NEXIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 40MG BASE/PACKET |
Prescription |
Yes |
Yes |
AB |
2006/10/20
|
ASTRAZENECA |
| 211751 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 40MG BASE/PACKET |
Prescription |
No |
No |
AB |
2020/03/23
|
CIPLA |
| 206055 |
002 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 40MG BASE/PACKET |
Prescription |
No |
No |
AB |
2023/06/07
|
ZYDUS PHARMS |
| 212651 |
004 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 40MG BASE/PACKET |
Prescription |
No |
No |
AB |
2025/03/05
|
TORRENT |
| 218948 |
003 |
ANDA |
ESOMEPRAZOLE MAGNESIUM |
ESOMEPRAZOLE MAGNESIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 40MG BASE/PACKET |
Prescription |
No |
No |
AB |
2025/04/15
|
AUROBINDO PHARMA LTD |